Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government, Drug Administration of Xinjiang Production and Construction Corps:

The year 2021 marks the centenary of the founding of the Communist Party of China (CPC) and the start of a new journey to fully build a modern socialist country by implementing the 14th Five-Year Plan. According to the 2021 national work conference on the supervision and administration of medical devices deployed for the further implementation of "the four most strict" requirement, strengthen the risk management of medical equipment, to further enhance the level of quality security and promote the development of high quality medical equipment industry in China, is now in medical equipment quality safety risk hidden governance matters related to notice the following:

I. Work objectives

(1) Comprehensive investigation of risks and hidden dangers. Local drug regulatory authorities at all levels have taken multiple measures to promote risk management, timely identify and eliminate emerging and biased problems, and firmly guard against systemic, regional and secondary safety risks.

2. Governance responsibilities are fully implemented. Medical device production and operation enterprises and users of the quality and safety of the main responsibility has been consolidated, enterprise quality management, risk investigation and other responsibilities are implemented to people. The regulatory responsibilities of drug regulatory departments at all levels have been thoroughly implemented, and the accountability governance system has been further improved.

(3) Comprehensive improvement in management. The compliance awareness of medical device manufacturing and operation enterprises and users continues to be enhanced, and the legal representative and principal person in charge of the enterprise further deepen their knowledge and understanding of laws and regulations and quality management system. Local drug regulatory authorities at all levels comprehensively sorted out and improved the shortcomings of the regulatory system and system, further enhanced their ability to perform duties in accordance with the law, and further improved the level of supervision.

4. Quality assurance was comprehensively strengthened. The quality management level and risk detection ability of medical device manufacturers and users have been effectively improved, the risk management ability of drug regulatory departments at all levels has been continuously improved, and the quality and safety guarantee level of medical device throughout the life cycle has been further strengthened.

Ii. Working principles

1. Combining comprehensive progress with emphasis on key areas On the basis of promoting enterprises' comprehensive self-examination and supervision departments' comprehensive investigation, we will focus on key products, key enterprises and key links to sort out risks one by one.

(2) Combine risk investigation and responsibility implementation. At the same time of risk investigation and management, we will fully implement the main responsibility for quality and safety of enterprises, and further strengthen the responsibility of local supervision.

(3) combining investigation and punishment of illegal acts with setting up typical examples. Implement the "four strictest" requirements, severely crack down on violations of laws and regulations, and actively play the exemplary role of excellent enterprises to promote the overall improvement of the quality and safety guarantee level of medical devices.

4. Integrating the development of governance system with the improvement of governance capacity Through the improvement of the governance system to promote the improvement of governance capacity, promote the high-quality development of the medical device industry.

Three, investigation and treatment focus

(1) Epidemic prevention and control medical devices. Priority should be given to the screening of novel coronavirus test reagents, ventilators, medical protective suits, medical masks and infrared thermometers for epidemic prevention and control, especially those enterprises approved for emergency production and transferred to cross-border production, as well as those enterprises with substandard products and defective quality systems.

(2) Centralized procurement of selected products with quantity. Focus on coronary stent and other national centralized procurement of selected products, focus on whether the production enterprises strictly audit raw materials and supplier management, whether the production process, quality control and finished product release control are in place, whether the traceability system is sound, whether the adverse events found timely investigation and evaluation; Whether the distribution unit of the selected products shall transport and store in strict accordance with the requirements of product instructions or labels, and make corresponding records; Whether the medical institutions do a good job in the procurement, acceptance, storage and other quality management of selected products in accordance with the provisions.

(3) Sterile and implanted medical devices. The organization carried out a comprehensive risk investigation for sterile and implantable medical device enterprises, focusing on high-value medical consumables such as artificial joints, iols, balloon dilators, defibrillators, occluders, orthopedic materials, staplers and disposable sterile syringes. Focus on whether raw material procurement and supplier management of production enterprises meet the requirements, whether key processes and special processes are identified and effectively controlled, and whether clean room (area) control meets the requirements. Whether the requirements of process inspection, finished product inspection and finished product release are strictly implemented, and the drug regulatory authorities shall inspect the whole project of sterile and implantable medical device manufacturers at least once a year; Whether the operating enterprise is engaged in the operation (online sales) of medical devices without permission (filing), whether the operating enterprise is engaged in the operation (online sales) of medical devices without registration certificate or filing certificate; Whether the user buys medical devices from suppliers without legal qualifications, whether the user buys or uses medical devices that are not registered, have no qualification documents, expired, invalid or eliminated. The supervision and inspection of sterile and implantable enterprises and users by drug regulatory departments shall be no less than 15% of the total number of relevant enterprises and units within the administrative region every year.

(4) Online sales of medical devices. Continue to carry out the "Clean Internet action", focusing on the screening of medical devices for epidemic prevention and control, medical devices that have received more complaints and public opinion concerns, and third-party platforms for online medical device trading services to fulfill their legal obligations. Focus on whether the product instructions and labels are consistent with the registered content; Whether the products are sold in accordance with the scope of application and intended use of the registered products; Whether the existence of product sales of product efficacy assertion, false publicity and other behaviors. The drug regulatory authorities shall supervise and inspect the third-party platforms of online medical device trading services no less than once a year, and the online sales enterprises no less than once every two years.

(5) Supervising the sampling and inspection of unqualified enterprises. Key investigation for many years of sampling inspection of the same breed of unqualified enterprises and many varieties of unqualified enterprises. Make full use of sampling inspection methods of medical device quality supervision to identify medical device manufacturers with potential risks and products that need to be focused on, such as infusion pumps, disposable nasal oxygen tubes, nerve and muscle stimulators, etc. In-depth analysis of historical sampling data, mining potential risks, urging enterprises to effectively rectify in place.

(6) Adverse event monitoring indicates that there may be risk enterprises. Focus on adverse events monitoring of manufacturers and medical devices that may have serious problems, focus on the effective operation of enterprise quality management system, check and confirm whether products have quality and safety risks, urge enterprises to take targeted risk control measures.

(7) Products and enterprises with frequent complaints and reports. Focus on injection with sodium hyaluronate, contact lenses, corneal shape mirror, rf heat therapy instrument, radio frequency ultrasonic skin de-fatting instrument, facial rf beauty instrument, artificial nose implants, youth myopia correction, condoms, spinal brace eye optical applied medical apparatus and instruments, medical apparatus and instruments, and in the name of the "machinery shop name mask" for sale of medical cold, in the name of the "machinery shop name toothpaste" Conduct the sales of cold compress gel, tooth desensitization and other medical equipment, comprehensively sort out the complaints and reports, and carry out follow-up investigation when necessary for the enterprises that have completed the investigation and disposal to ensure that the investigation and disposal measures are in place; Timely investigation shall be carried out on the clues of problems that have not yet been investigated and disposed of, to ensure thorough investigation and verification, and effectively eliminate hidden risks of product quality and safety.

(8) Innovative medical devices and conditional approval related enterprises. Country report related companies list in time, the drug regulatory department at the provincial level key screening related enterprise quality management system audits, raw materials procurement, production process control, finished product inspection and adverse event monitoring system, especially the innovation of medical equipment and product innovations on whether the production process of effective control of And whether the conditions attached to the conditional approval products have been effectively implemented.

(9) commissioned production by the medical device registrant. Focus on whether medical device registrants establish and improve the quality management system, whether they have the ability to ensure the quality and safety of the whole life cycle of medical devices, whether they effectively carry out self-inspection of the quality management system, and whether they carry out strict quality management for the entrusted manufacturers.

Innovating working methods

(1) Carry out risk consultation seriously. Provincial drug regulatory departments should organize quarterly risk meetings, study and judge trends and systematic problems, implement list management of risks and hidden dangers, and timely dispose of them and sell them one by one.

(2) Actively innovating inspection models. Drug regulatory authorities at all levels can carry out investigation and management in various forms, such as cross-inspection, joint inspection, entrusted inspection and "Internet + supervision", and organize "looking back" on key enterprises by means of follow-up inspection and third-party evaluation.

3. We will investigate and prosecute laws and regulations. If the self-examination, rectification and responsibility of the enterprise are not in place, the drug regulatory department shall interview the legal representative of the enterprise, and the results of the interview shall be published to the public. Those suspected of violating laws and regulations shall be investigated and dealt with in accordance with the law, punished according to people's requirements, and strengthened connection between execution and discipline.

4. Strengthening exemplary leadership Taking the implementation of the new Regulations on The Supervision and Management of Medical Devices as an opportunity, the training of enterprises is intensified, and industry associations are used as Bridges to organize enterprises to carry out exchanges and learning. From the quality management system construction, adverse event monitoring and other aspects of classification to select outstanding exemplary enterprises, give full play to the exemplary leading role, to promote enterprises to jointly improve the quality management level.

5. Work arrangement

(1) Self-inspection and rectification. Medical device manufacturers, operating enterprises (including online sales enterprises), users and third-party platforms providing online trading services shall conduct a comprehensive self-examination in accordance with the requirements (Annex 1, 2, 3 and 4), form a ledger of risks and hidden dangers found in self-examination, formulate a rectification plan, and take rectification measures to eliminate risks and hidden dangers in time. The self-inspection form, rectification plan and implementation of rectification measures shall be submitted to the local drug regulatory department before June 30.

(2) Inspection and investigation. Drug regulatory departments at all levels have intensified their inspection of key enterprises and varieties, urging enterprises to "conduct true self-inspection, rectify early, seize management and ensure quality". It is necessary to highlight key points and compacting responsibilities, formulate the list of supervision responsibilities of medical device production and operation enterprises and users, and specify the responsibilities to specific personnel. In light of the actual situation of the supervision of the jurisdiction, we should comprehensively sort out the shortcomings and deficiencies of supervision, form a list of risks and hidden dangers and conduct self-inspection and rectification of the ledger, implement rectification within a specified period, and realize the management of the list and sales number one by one.

(3) Summary and promotion. Drug regulatory authorities at all levels should summarize the self-inspection, rectification, investigation and treatment of enterprises in a timely manner, sort out common problems and good practices, refine and improve the regulatory system, form a long-term mechanism, and comprehensively improve the level and ability of supervision.

Enterprises' self-examination and rectification should be carried out throughout the whole process of the investigation and treatment of risks and hidden dangers, and regulatory departments' supervision, inspection, improvement and upgrading should be carried out throughout the whole process. The summary report and summary form (annexes 5, 6, 7, 8 and 9) shall be submitted to the National Bureau before December 10, 2021. Summary report contents should include: the relevant medical equipment production and operation enterprises within their respective administrative areas, the use of hidden unit and drug regulatory risk, found that the main problems and the main measures and risk in consultation with the situation, the rules and regulations stable cross training situation, build a long-term mechanism, and relevant opinions and Suggestions, etc.

Six, work requirements

1. Improve our political standing. Drug regulatory departments at all levels should conscientiously implement the requirements of the National Drug supervision and management and the Construction of clean Government work conference, organize the work with the "four strictest" requirements, and organically combine the investigation and governance work with the celebration of the 100th anniversary of the founding of the Party, the planning of the "14th Five-year Plan" and the promotion of 2021 key work.

2. Strengthening organizational support. All provincial drug regulatory departments should strengthen the overall planning of work, do a good job of task decomposition, refine the implementation plan, and ensure that all work is completed on time. We will encourage local governments to use it to investigate and control risks and hidden dangers.

(3) Intensify publicity efforts. Drug regulatory departments at all levels should work closely with the news media, industry associations and other sectors of society to increase the publicity of typical demonstration enterprises, strengthen the popularization of medical devices and the publicity of laws and regulations, and deepen the public's understanding and understanding of the medical device industry.

(4) Timely reporting of information. If the drug regulatory department at the provincial level discovers common problems and major quality risks during the investigation and control of hidden risks, it shall timely report to the National bureau and inform the local government.

The national Bureau will organize a supervision group, timely supervision of the investigation and governance work around the city, select some provincial and municipal regulatory departments to carry out research and discussion activities, summarize the experience and practices that can be promoted and copied around the local government, and inform the local government. Relevant work will be included in the relevant annual performance assessment indicators in each region.

Contact information:

Xu Song (production) 010-88330651

Yang Xiao Mo (business use) 010-88330692

Wang Xiaoxue (Adverse event monitoring and supervision sampling test) 010-88330619

Mail box: fxpczl@nmpa.gov.cn

Appendix: 1.2021 Self-check Table of Risks and Hidden Dangers for Medical device Manufacturers

2.2021 Medical device business enterprise risk self-check table

3.2021 Self-check Form of Hidden Risks of Medical Device Use unit

4.Self-check Form of risks and hidden dangers of third-party platform of Medical device online trading Service in 2021

5.Medical device risk management in 2021 summary of manufacturers

6.2021 Medical device risk investigation, management, operation and use of units summary table

7.Medical device risk management network trading enterprises in 2021 summary table

8.2021 Medical device risk management network monitoring clue disposal summary table

9. Summary of the investigation and treatment of potential risks of medical device Regulatory Departments in 2021

Comprehensive Division, SFDA

March 26, 2021